Program Delegation #9

Pursuant to the authority vested in the Director, Indian health Service, by the Assistant Secretary for health on February 4,1988 and in accordance with authority delegated to PHS Agency Heads in their dual capacity as heads of Federal agencies and head of Federal laboratories. I hereby delegate the following authority:

All of the authorities under the Stevenson - Wydler Technology innovation Act of 1980 (15 U.S.C. 3701 et. seq.) as amended by the Federal Technology Transfer Act of 1986, P.L. 99-502, and under Executive Order No. 12591 of April 10, 1987, as amended, to the functions of their respective agencies.

TO WHOM DELEGATED

AREA OF AUTHORITY

Deputy Director, Indian Health Service (IHS)

IHS-wide

AUTHORITY TO REDELEGATE

Any authority not retained by the Secretary of Health and Human Services, Director, IHS, and Deputy Director, IHS, may not be further redelegated.

RETENTION OF AUTHORITY

The Secretary of Health and Human Services has retained the authority to promulgate regulations and submit reports to the Congress.

This delegation does not include the authority to:

approve agreements and contracts with invention management organizations, such as the National Technical Information Service, under Section 11(a)(2), and;

propose necessary statutory changes regarding conflict of interest to be forwarded to its authorizing committee in Congress under Section ll(c)(3)(B).

RESTRICTION AND LIMITATIONS

The following authorities are retained by the Director, IHS, and may not be redelegated:

Section 11 - Cooperative Research and Development Agreements:

(b)(3) - The authority to waive, subject to reservation by the Government of a nonexclusive, irrevocable, paid-up license to practice the invention or have the invention practiced throughout the world by or on behalf of the Government, in advance, in whole or in part, any right of ownership which the Federal Government may have to any subject invention made under the agreement by a collaborating party or employee of a collaborating party;

(b)(4) - The authority to the extent consistent with any applicable agency requirements and standards of conduct, to permit employees or former employees of the laboratory to participate in efforts to commercialize inventions they made while in the service of the United States.

(c)(3)(A) - The authority to review employee standards of conduct for resolving potential conflicts of interest to make sure they adequately establish guidelines for situations likely to arise through the use of this authority, including but not limited to cases where present or former employees or their partners negotiate, licenses or assignments of titles to inventions or negotiate cooperative research and development agreements with Federal agencies (including the agency with which the employee involved is or was formally employed).

Section 13 - Distribution of Royalties Received by Federal Agencies:

(a)(1) - The authority to retain any royalties of other income, except as provided in paragraph (a)(2) of this section, from the licensing or assignment of inventions under agreements entered into under section 11, and inventions of Government- operated Federal laboratories licensed under section 207 of Title 35, U.S.C., or under any other provision of law.

(a)(l)(A)(i) - The authority to pay at least 15 percent of the royalties or other income the agency receives on account of any invention to the inventor (or co-inventors) if the Inventor (or each such co-inventor) was an employee of the agency at the time the invention was made.

The following authorities may be exercised only by the Deputy Director, Indian Health Service:

Section 11 - Cooperative Research and Development Agreements:

(C)(5)(A) - The authority to disapprove or require the modification of cooperative research and development agreements and licensing agreements within a 30-day period, beginning on the date the agreement is presented to the head of the PHS agency by the head of the laboratory concerned;

(c)(5)(B) - The authority to transmit a written explanation of such disapproval or modification to the head of the laboratory concerned, in any case in which the head of the PHS agency disapproves or requires the modification of an agreement presented under this section.

After providing prior notice, the Assistant Secretary for Health may elect to exercise any authority included in this delegation.